← Back to catalogue
Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref GSD01-1600
Identity
- Trade Name
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System EUDAMEDFDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System EUDAMEDGold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit FDA UDI
- Model / Reference
- GSD01-1600 EUDAMEDFDA UDI
- Description
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B350GSD0116000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B350GSD0116000 EUDAMED
- FDA Product Code
- GMQ FDA UDI
- EMDN Code
- W0105010399 SYPHILIS REAGENTS OTHER EUDAMED
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System by Gold Standard Diagnostics, LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B350GSD0116000 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
- EUDAMED SRN
- US-MF-000027142
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c5cbc65e-5338-44d5-b30b-a778ba6aaa10 61 fields · synced Jun 8, 2026
- FDA UDI bbf37193-67f5-406b-89d3-3caa92dd4d87 34 fields · synced May 30, 2026